Exploring the Novel Value of PSMA PET in Sjögren's Syndrome: Integrated Analysis With Established FAPI PET Imaging

NCT07324733 · tracked via the Priya Life Science China tracker

Sponsor

Peking Union Medical College Hospital

Phase

Not applicable

Started

2023-10-01

Last updated

2026-07-29

Condition(s) studied

Primary Sjögren SyndromePET

Investigational drug(s) / intervention(s)

⁶⁸Ga-PSMA PET/CT⁶⁸Ga-FAPI PET/CT

⁶⁸Ga-PSMA PET/CT: PSMA PET imaging performed for clinical evaluation in prostate cancer patients, used as a comparator for physiologic salivary gland PSMA uptake.

⁶⁸Ga-FAPI PET/CT: FAPI PET imaging to assess inflammatory activity (FAPI) in patients with primary Sjögren's syndrome.

Study summary

Primary Sjögren's syndrome (pSS) is a chronic autoimmune exocrinopathy characterized by lymphocytic infiltration, progressive destruction of salivary gland acini, and varying degrees of functional impairment and fibrosis. Conventional imaging provides limited ability to simultaneously evaluate glandular function and inflammatory activity, leading to challenges in disease staging and treatment decision-making. This study explores a conceptual dual-tracer imaging framework using PSMA PET and FAPI PET to delineate complementary biological processes in pSS.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Age 18-80 years; * Fulfillment of the 2016 ACR-EULAR Classification Criteria for pSS at enrollment. OR diagnosis of a solid tumor scheduled for FAPI PET imaging Exclusion Criteria: * Combined with tumors or other connective tissue diseases (for SS group); * Patients who are currently using hormones/biological agents (for both groups)； * Pregnancy or lactation

Primary outcome measure(s)

Difference in Salivary Gland PSMA Uptake Across Groups — Baseline
Quantitative comparison of PSMA PET uptake parameters (SUVmax, SUVmean) of the parotid glands among three groups: pSS patients, individuals with normal salivary glands, and prostate cancer patients.

Trial sites (1)

Facility	City	Region	Status
Peking Union Medical College Hospital	Beijing	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07324733 on ClinicalTrials.gov ↗ ← All trials in China